Device and method for positioning an electrode in a body cavity

• US 9,872,981 B2
• Filed: 05/08/2015
• Issued: 01/23/2018
• Est. Priority Date: 09/28/2010
• Status: Active Grant

• Current Assignee: BioTrace Medical, Inc. (Merit Medical Systems, Inc.)
• Original Assignee: BioTrace Medical, Inc. (Merit Medical Systems, Inc.)
• Inventors: Sparks, Kurt, Garai, Ellis, Swaminathan, Aravind, Dietch, Laura, Sicotte, Marcel
• Primary Examiner(s): Gedeon, Brian T
• Application Number:
  US14/707,246
• Publication Number:
  US 20150320330A1
• Time in Patent Office: 991 Days
• Field of Search: None
• CPC Class Codes: A61B 2017/22071 Steering
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/024 Detecting, measuring or recording pulse rate or heart rate A61B5/0205, A61B5/021 take precedence
• CPC Class Codes: A61B 6/12 Arrangements for detecting or locating foreign bodies
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: A61N 1/057 Anchoring means; Means for fixing the head inside the heart
• CPC Class Codes: A61N 1/0573 chacterised by means penetrating the heart tissue, e.g. helix needle or hook
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 2001/0578 having means for removal or extraction
• CPC Class Codes: A61N 2001/058 Fixing tools

Abstract

Electrical sensing/stimulation apparatuses for positioning at least one electrode within body tissue are provided. An electrical sensing/stimulation apparatus may comprise an elongate lead body having at least one internal lumen, at least one sensing/stimulation electrode, a deployable/retractable displacement member that moves or biases at least one electrode towards a prescribed direction by the user, a tissue attachment mechanism for affixing the distal segment of the device to body tissue, and an atraumatic distal lead body termination. In a retracted configuration, the attachment mechanism is positioned substantially within the distal segment of the lead body, and in the deployed configuration, the attachment mechanism extends from the axis of the lead body to engage body tissue.

Claims

1. An electrical sensing/stimulation apparatus for positioning at least one electrode within body tissue, the electrical sensing/stimulation apparatus comprising:

an elongate lead body having a longitudinal axis;

at least one sensing/stimulation electrode coupled to the elongate lead body;

a deployable/retractable displacement member coupled to the elongate lead body and adapted to move or bias the at least one electrode towards a prescribed direction by a user; and

a tissue attachment mechanism adapted to affix a distal segment of the elongate lead body to body tissue, the tissue attachment mechanism having a retracted configuration and a deployed configuration,

wherein in the retracted configuration the tissue attachment mechanism is positioned substantially within the at least one internal lumen, and in the deployed configuration the tissue attachment mechanism extends from the longitudinal axis of the elongate lead body to engage body tissue, and

wherein the tissue attachment mechanism comprises a plurality of tissue attachment members adapted to extend from a common port of the elongate lead body, and

wherein two or more of the tissue attachment members of the plurality of tissue attachment members are adapted to diverge from one another when extended from the common port.

2. The electrical sensing/stimulation apparatus of claim 1, wherein the elongate lead body has one or more ports through which the tissue attachment mechanism is configured to deploy.

3. The electrical sensing/stimulation apparatus of claim 1, wherein a proximal portion of the elongate lead body is configured to couple with an external generator.

4. The electrical sensing/stimulation apparatus of claim 3, wherein the proximal portion of the elongate lead body is configured to couple with the external generator through a magnetic coupling.

5. The electrical sensing/stimulation apparatus of claim 3, wherein the proximal portion of the elongate lead body is configured to couple with the external generator through an extension coupling adapted to axially lengthen or contract.

6. The electrical sensing/stimulation apparatus of claim 1, wherein the at least one sensing/stimulation electrode comprises a first electrode and a second electrode.

7. The electrical sensing/stimulation apparatus of claim 6, wherein the deployable/retractable displacement member is disposed between the first and second electrodes.

8. The electrical sensing/stimulation apparatus of claim 1, wherein the deployable/retractable displacement member comprises an expandable member having a collapsed configuration and an expanded configuration.

9. The electrical sensing/stimulation apparatus of claim 8, wherein the expandable member is adapted to deploy out of a lateral side of the elongate lead body.

10. The electrical sensing/stimulation apparatus of claim 8, wherein the expandable member in the collapsed configuration does not extend from an outer surface of the elongate lead body.

11. The electrical sensing/stimulation apparatus of claim 8, wherein the expandable member is at least partially folded onto itself in the collapsed configuration.

12. The electrical sensing/stimulation apparatus of claim 8, further comprising a radiopaque marker mounted on an outer surface of the expandable member.

13. The electrical sensing/stimulation apparatus of claim 12, wherein the radiopaque marker is expandable in conjunction with the expandable marker.

14. The electrical sensing/stimulation apparatus of claim 12, wherein the expandable element in the expanded configuration is shaped to match the cavity of a bodily organ or space.

15. The electrical sensing/stimulation apparatus of claim 14, wherein the bodily organ or space is at least a part of a right ventricle, a left ventricle, a right atrium, a left atrium, an aorta, a vena cava, an artery, a vein, a bladder, a ureter, a uterus, a nasal cavity, an oral cavity, an esophagus, a stomach, an intestine, a gall bladder, a colon, or a rectum.

16. The electrical sensing/stimulation apparatus of claim 1, wherein in the deployed configuration, the tissue attachment mechanism extends from the longitudinal axis of the elongate lead body to penetrate into the body tissue.

17. The electrical sensing/stimulation apparatus of claim 1, wherein the plurality of tissue attachment members is adapted to extend from the longitudinal axis of the elongate lead body.

18. The electrical sensing/stimulation apparatus of claim 1, wherein one or more tissue attachment member of the plurality of tissue attachment members comprises a curved loop.

19. The electrical sensing/stimulation apparatus of claim 1, wherein two or more tissue attachment members of the plurality of tissue attachment members are configured to extend from different ports of the elongate lead body.

20. The electrical sensing/stimulation apparatus of claim 19, wherein the two or more of the tissue attachment members of the plurality of tissue attachment members are adapted to be co-planar when extended.

21. The electrical sensing/stimulation apparatus of claim 1, wherein the common port has a length allowing the elongate lead body to translate over a linear portion of one or more of the tissue attachment members.

22. The electrical sensing/stimulation apparatus of claim 21, wherein one or more of the tissue attachment members have a distal wire loop and a straightened distal-most portion distal of the distal wire loop.

23. The electrical sensing/stimulation apparatus of claim 1, wherein two or more of the tissue attachment members diverge from one another by an angle of less than or equal to 270 degrees.

24. The electrical sensing/stimulation apparatus of claim 1, wherein the at least one tissue attachment member comprises a hollow needle having an inner lumen through which one or more anchoring elements are advanced from when the at least one tissue attachment member is deployed.

25. The electrical sensing/stimulation apparatus of claim 1, further comprising an atraumatic distal lead body termination.

26. The electrical sensing/stimulation apparatus of claim 25, wherein the atraumatic distal lead body termination comprises a sensing/stimulation electrode.

27. The electrical sensing/stimulation apparatus of claim 1, further comprising a proximal handle coupled to the elongate lead body.

28. The electrical sensing/stimulation apparatus of claim 1, wherein the proximal handle comprises one or more controls for one or more of activating the at least one sensing/stimulation electrode, deploying or retracting the deployable/retractable displacement member, or deploying or retracting the tissue attachment mechanism.

29. The electrical sensing/stimulation apparatus of claim 1, wherein the proximal handle comprises one or more displays for indicating one or more of a relative position of the tissue attachment mechanism, a sensed resistance of tissue engaged by the tissue attachment mechanism, or a sensed amount of current through the tissue engaged by the tissue attachment mechanism.

30. The electrical sensing/stimulation apparatus of claim 1, wherein the elongate lead body has an internal lumen, and wherein the electrical sensing/stimulation apparatus further comprises a torque member within the inner lumen and adapted to torque the elongate lead body.

31. The electrical sensing/stimulation apparatus of claim 30, wherein the torque member is fixedly attached to the elongate lead body.

32. The electrical sensing/stimulation apparatus of claim 30, wherein the torque member comprises a hypotube.

33. The electrical sensing/stimulation apparatus of claim 30, further comprising a shaping wire configured for placement within the internal lumen of the elongate lead body to provide a predetermined shape to the elongate lead body.

34. The electrical sensing/stimulation apparatus of claim 33, wherein the shaping wire is configured to axially translate within the inner lumen.

35. The electrical sensing/stimulation apparatus of claim 1, wherein the elongate lead body comprises an O-ring disposed in a proximal portion thereof, the O-ring being adapted to prevent fluid from leaking proximally therethrough.

36. A method for positioning an electrical sensing/stimulation device within body tissue, the method comprising:

advancing an elongate lead body of the electrical sensing/stimulation device to position the elongate lead body at a target site in a bodily cavity;

torqueing the elongate lead body to align at least one tissue attachment member of the electrical sensing/stimulation device with a target tissue in the target site;

deploying a displacement member to bias the elongate lead body and the at least one tissue attachment member against the target tissue; and

actuating the at least one tissue attachment member to extend from at least one tissue anchor deployment port on the elongate lead body and into the target tissue to affix a distal portion of the elongate lead body and at least one electrode of the electrical sensing/stimulation device to the target tissue,

wherein the at least one tissue attachment member comprises a plurality of tissue attachment members, and

wherein actuating the at least one tissue attachment member to extend from the at least one tissue deployment port comprises actuating the plurality of tissue attachment members to extend from a common tissue deployment port, and

wherein two or more attachment members diverge from one another when deployed from the common tissue deployment port.

37. The method of claim 36, further comprising verifying proper affixation of the distal portion of the elongate lead body to the target tissue.

38. The method of claim 37, wherein verifying proper affixation of the distal portion of the elongate lead body to the target tissue comprises fluoroscopically imaging the bodily cavity with the elongate lead body positioned therein.

39. The method of claim 38, wherein fluoroscopically imaging the bodily cavity comprises identifying one or more radiopaque markers coupled to one or more of the elongate lead body, the at least one tissue attachment member, or the displacement member.

40. The method of claim 36, further comprising sensing a physiological parameter with the at least one electrode affixed to the target tissue.

41. The method of claim 36, further comprising stimulating the target tissue with the at least one electrode.

42. The method of claim 36, further comprising collapsing the displacement member and retracting the at least one tissue attachment member after affixation to the target tissue, so as to release the affixation of the distal portion of the elongate lead body and the at least one electrode from the target tissue.